The UK’s Prime Minister last week singled out the EU pharmaceuticals regulatory regime as one in which the UK could continue to participate post Brexit. The pharmaceuticals industry, which has been asking for continued alignment since the UK referendum, welcomes this development. However, the proposal and its apparent inherent contradictions – in the context of the ongoing EU/UK negotiations – may not provide enough clarity to allow pan-EU companies sufficient confidence in the post-Brexit landscape to put their contingency planning on hold.

In a speech delivered at London’s Mansion House on Friday 2 March, Theresa May has suggested that, following Brexit, the UK could become an “associate member” of the European Medicines Agency (EMA). She said that she understood that this would involve abiding by the rules of the EMA and “making an appropriate financial contribution”. Mrs May also said “associate membership of [such] agencies is the only way to meet our objective of ensuring that these products only need to undergo one series of approvals, in one country.”

It is encouraging to see that the UK puts a continued participation in the EMA on the Brexit negotiating table, but questions remain about the feasibility of an associate membership of the EMA when leaving the single market. Norway, Liechtenstein and Iceland are within the single market but have no decision making powers; and it is not only the political argument: Mrs May did not explain what it would mean to “abide by” the rules of the EMA, given she plans to give the UK parliament the ultimate right to accept or reject any piece of EU legislation. Having UK courts decide over matters that can influence the parameters in which EMA scientific assessments take place may simply be a deal-breaker for the EU.

Michel Barnier, the EU’s chief Brexit negotiator, reacted by welcoming the clarity of leaving the single market offered by Theresa May’s speech as well as the acknowledgement of trade offs by the UK’s PM. However, even if the UK were to accept concessions such as observer-only status to the EMA, renouncing the UK parliament’s privilege to reject EU pharmaceutical laws, and agreeing to the jurisdiction of the European Court of Justice in all EMA matters, it remains to be seen if the EU is able to agree to extend access to the EU pharma regulatory system to a country that will not be part of the single market.

For Mike Thompson, the chief executive of the ABPI, close cooperation on the regulation of medicines as proposed by May is only one part of the challenge. As highlighted by the BIA, 82 million patient packs travel between the UK and EU each month. Making sure the supply of medicines across the UK and EU is uninterrupted from day one of Brexit is essential for patient safety and needs to be a priority for negotiators.

The Brexit Health Alliance also praised this development. It has long called for certainty and cooperation to safeguard the future of research into new medicines and medical technologies, cautioning that around 750 UK-led clinical trials that cover multiple EU member states could be at risk without an urgent plan on how to approve and mange these multi-national trials post-Brexit. It warns that up to 120,000 prostate cancer patients throughout Europe could be affected, and flags the particular risk to research into rare childhood diseases such as neuroblastoma.

For more information please contact Julia Gillert or Rachel Wilson of our London office, or Els Janssens of our Abu Dhabi office.

Els Janssens is a senior associate in our Abu Dhabi office and provides knowledge management support to Baker & McKenzie’s global and MENA Pharmaceutical and Healthcare industry group. Els started her career in 2000 at Baker and McKenzie in Brussels focusing her practice on pharmaceutical law and commercial litigation. She has worked six years in London as a legal adviser with the European Medicines Agency (EMA). During this period she has supported the EMA’s activities in medicines oversight and regulation and interacted with the European Commission on legal matters relating to medicinal products. She also worked one year as senior legal counsel in Johnson & Johnson’s European legal department providing regulatory advice regarding various medicinal products and supporting the public affairs function on new legislation.

Julia Gillert is a Senior Associate in the Corporate Department of Baker & McKenzie's London office and is a key member of the Healthcare industry group within the London office and European and Global networks. Julia advises both domestic and international companies in the med-tech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters. Julia has contributed to a variety of regulatory healthcare related publications and practice handbooks and co-edits the firm's European Healthcare Newsletter. Julia sits on the ABHI's Legal Issues Committee.

A draft Withdrawal Agreement between the EU and the U.K. has been published by the European Commission (28/02/2018), which puts the agreement on Phase 1 of Brexit negotiations reached in December into a legal document.

In this agreement, the U.K. is required to “make available without delay” the marketing authorisation application of a drug approved by the U.K. competent authorities before the end of the Brexit transition period, if an EU Member State or the European Medicines Agency requires it.

U.K. notified bodies should also provide information to other EU countries about their certification activities until the end of the transition period, should a certificate holder require it (e.g. a medical device manufacturer). Notified bodies in the EU are also required to do the same for the U.K.

The agreement also says that EU rules would still apply if a new application for a supplementary protection certificate (for drugmakers and pesticide manufacturers) or for an extension was made before December 31, 2020 – the end of the transitioning period.

The agreement also says that the U.K. will lose access to any EU network, database and information system after the transition period. This is expected to include the EU Early Warning and Response System which monitors public health threats and also the Rapid Alert System for Food and Feed which sends alerts about potential threats detected in the food supply. This may also affect access to EudraVigilance, the system for managing and analysing information on suspected adverse reactions to medicines which have been authorised or are being studied in clinical trials in the European Economic Area.

For further information please contact Julia Gillert of our London office or Els Janssens of our Abu Dhabi office.

Julia Gillert is a Senior Associate in the Corporate Department of Baker & McKenzie's London office and is a key member of the Healthcare industry group within the London office and European and Global networks. Julia advises both domestic and international companies in the med-tech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters. Julia has contributed to a variety of regulatory healthcare related publications and practice handbooks and co-edits the firm's European Healthcare Newsletter. Julia sits on the ABHI's Legal Issues Committee.

Els Janssens is a senior associate in our Abu Dhabi office and provides knowledge management support to Baker & McKenzie’s global and MENA Pharmaceutical and Healthcare industry group. Els started her career in 2000 at Baker and McKenzie in Brussels focusing her practice on pharmaceutical law and commercial litigation. She has worked six years in London as a legal adviser with the European Medicines Agency (EMA). During this period she has supported the EMA’s activities in medicines oversight and regulation and interacted with the European Commission on legal matters relating to medicinal products. She also worked one year as senior legal counsel in Johnson & Johnson’s European legal department providing regulatory advice regarding various medicinal products and supporting the public affairs function on new legislation.

The UK’s medicines regulator, the MHRA, published an update on 16 January to pharmaceutical companies on preparations for Brexit. The information highlighted the guidelines that have been adopted by the European Council when it was agreed that sufficient progress has been made to move on to the second stage of negotiations. The guidelines reconfirm the EU’s desire to establish a close future partnership with the UK.

The UK’s position on medicines regulation remains clear; the UK is fully committed to continuing the close working relationship with its European partners, in the interests of health and safety. It aims to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines and be assured that their safety is protected through the strongest regulatory framework and sharing of data. Further, the UK intends to secure an implementation period based on the existing structure of EU rules and regulations as soon as possible and also plans to agree “a deep and special future partnership”.

However, should there be no implementation period with the EU, the MHRA suggests there would be no sudden changes to the UK regulatory framework as the European Union (Withdrawal) Bill will convert the existing EU legislative framework into the law at the moment of exit. The MHRA also said it will be “pragmatic” in establishing UK regulatory requirements, giving enough notice to allow companies to implement any change. The MHRA would make use of information they already have to complete administrative tasks to ensure continuity of work and licences and build on the existing relationship between MHRA and firms ensuring minimum disruption and burden on companies.

The MHRA has emphasised that the UK’s current regulatory relationship with the European network is unchanged as it is still a full member of the EU and expects to be treated as such.

Brexit Planning for Life Sciences by UK Government

On 23 January, the UK Health Secretary Jeremy Hunt sought to reassure MPs about Brexit contingency planning. However, declining to give specifics about the no-deal contingency planning for the life science industry, Hunt stated the reason was to maintain “strategic ambiguity” so that the UK government could procure the best deal possible with the EU, rather than a lack of transparency.

NHS Confederation Warnings of Market Access Delays

Industry has said that it needs at least a two-year transition period after March 2019 due to complex regulatory requirements and has been waiting for more guidance from regulators and policymakers about when to implement transition plans. There is a fear that companies run the risk of drug delays and shortages if they do not act quickly. According to a report published on 29 January from the Brexit Health Alliance – a coalition of doctors, NHS bosses and pharma companies – patients could face long delays obtaining new drugs or be denied access to them altogether as a result of Brexit. The report warns that the NHS may find itself unable to access newly developed medications for up to a year compared with the other 27 EU nations once Britain leaves in March next year.

EMA Survey of UK Pharma

In order to minimise such disruption, and to help ‘nudge’ companies who have not yet taken any action to start planning for any regulatory steps required for centrally-authorised products to remain on the EU market post-Brexit, the European Medicines Agency (EMA) announced on 23 January that it is sending a questionnaire to pharma companies located in the UK to check what their post Brexit plans are. The results of this survey will drive EMA’s own contingency planning.

Milanese Challenge to EMA’s Amsterdam Relocation

Separately, it was announced on 31 January by a court spokesperson that cases have been filed by both the Italian government and the municipality of Milan at the Court of Justice of the European Union asking for the decision of relocating the EMA to Amsterdam to be annulled. The Italian Prime Minister, Paolo Gentiloni, and the Mayor of Milan, Giuseppe Sala, previously announced their intention to reopen the decision after the EMA boss Guido Rasi said that the temporary building offered by the Dutch authorities to use until the permanent building is ready was not “optimal”. Italy argues that the Netherlands is not able to fulfil the commitments it made in its application for the EMA. Milan’s bid to host the agency narrowly lost to Amsterdam, when a tied vote led to the drawing of lots.

For further information please contact Julia Gillert of our London office or Els Janssens of our Abu Dhabi office.

Julia Gillert is a Senior Associate in the Corporate Department of Baker & McKenzie's London office and is a key member of the Healthcare industry group within the London office and European and Global networks. Julia advises both domestic and international companies in the med-tech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters. Julia has contributed to a variety of regulatory healthcare related publications and practice handbooks and co-edits the firm's European Healthcare Newsletter. Julia sits on the ABHI's Legal Issues Committee.

Els Janssens is a senior associate in our Abu Dhabi office and provides knowledge management support to Baker & McKenzie’s global and MENA Pharmaceutical and Healthcare industry group. Els started her career in 2000 at Baker and McKenzie in Brussels focusing her practice on pharmaceutical law and commercial litigation. She has worked six years in London as a legal adviser with the European Medicines Agency (EMA). During this period she has supported the EMA’s activities in medicines oversight and regulation and interacted with the European Commission on legal matters relating to medicinal products. She also worked one year as senior legal counsel in Johnson & Johnson’s European legal department providing regulatory advice regarding various medicinal products and supporting the public affairs function on new legislation.

The European Medicines Agency (EMA) and the European Commission have published a first update of the initial questions-and-answers document that was published at the end of May 2017. The updated guidance, which was published on 1 December, includes additional information on how the UK’s withdrawal from the EU will affect marketing applications and authorisations for different types of medicinal products, for instance, generic, hybrid and biosimilar medicines. This updated Q&A should be read in conjunction with EMA’s first version of its procedural guidance published on 28 November. Please see previous post here.

Julia Gillert is a Senior Associate in the Corporate Department of Baker & McKenzie's London office and is a key member of the Healthcare industry group within the London office and European and Global networks. Julia advises both domestic and international companies in the med-tech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters. Julia has contributed to a variety of regulatory healthcare related publications and practice handbooks and co-edits the firm's European Healthcare Newsletter. Julia sits on the ABHI's Legal Issues Committee.

Els Janssens is a senior associate in our Abu Dhabi office and provides knowledge management support to Baker & McKenzie’s global and MENA Pharmaceutical and Healthcare industry group. Els started her career in 2000 at Baker and McKenzie in Brussels focusing her practice on pharmaceutical law and commercial litigation. She has worked six years in London as a legal adviser with the European Medicines Agency (EMA). During this period she has supported the EMA’s activities in medicines oversight and regulation and interacted with the European Commission on legal matters relating to medicinal products. She also worked one year as senior legal counsel in Johnson & Johnson’s European legal department providing regulatory advice regarding various medicinal products and supporting the public affairs function on new legislation.